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NCT02927938 · ADVERSE EVENTS

Adverse events

Leukemia Stem Cell Detection in Acute Myeloid Leukemia · Source last updated 2022-04-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Graft Versus Host Disease (GVHD) events were collected from the time of consolidation HCT through long term follow-up (up to approximately 5 years). - Acute GVHD: Confirmed GVHD within 100 days of HCT. - Chronic GVHD: Confirmed GVHD 100 days or more after HCT.
Other-event reporting threshold
0%

Both cytarabine-based consolidation chemo and HCT are considered standard of care for this disease population. With the exception of GVHD, an event of clinical interest, adverse events experienced by the subjects were not recorded in the dataset or included in the safety analysis. Each occurrence of GVHD, in evaluable subjects who received HCT, was graded by the investigator according to accepted institutional practice: CIBMTR grading for Acute GVHD; NIH Consensus criteria for Chronic GVHD.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Evaluable Cohort - Transplant Arm

Standard of Care Consolidation (HCT) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: 1. Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) 2. Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) 3. Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT); HMA-based induction subjects: Are candidates for (as determined by the investigator) and receive HCT Allogeneic HCT: Allogeneic HCT

0 / 10 / 10 / 1
Evaluable Cohort - Consolidation Chemo Arm

Standard of Care Consolidation (cytarabine-based chemo) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: 1. Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) 2. Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) 3. Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT) Consolidation chemotherapy: Cytarabine-based consolidation chemotherapy

0 / 60 / 61 / 6
Observational Cohort 1

Enrolled subjects who do not achieve a CR to induction therapy, regardless of diagnostic phenotype. Following completion of induction therapy and remission bone marrow aspirate, if a subject is determined to not have achieved a complete remission to induction therapy, he or she would be included in observational cohort 1.

0 / 40 / 40 / 4
Observational Cohort 2

Enrolled subjects who achieve a CR to induction therapy but meet one or more of the following criteria: * Lack the immunophenotype of interest, * Cytarabine based induction subjects: Are not candidates for \[as determined by the investigator (e.g. unfit or refusal)\] and do not receive consolidation therapy (cytarabine-based chemotherapy or HCT) * HMA-based induction subjects: Are not candidates for \[as determined by the investigator (e.g. unfit, lack of donor, refusal)\] and do not receive HCT Final investigator determination of fit-ness can occur at any time until the start of consolidation therapy. HMA-based induction subjects will not receive consolidation cytarabine-based chemotherapy as part of the evaluable cohort if they do not receive HCT.

0 / 70 / 74 / 7

Group identifiers: EG000: Evaluable Cohort - Transplant Arm · EG001: Evaluable Cohort - Consolidation Chemo Arm · EG002: Observational Cohort 1 · EG003: Observational Cohort 2

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      description
      Both cytarabine-based consolidation chemo and HCT are considered standard of care for this disease population. With the exception of GVHD, an event of clinical interest, adverse events experienced by the subjects were not recorded in the dataset or included in the safety analysis. Each occurrence of GVHD, in evaluable subjects who received HCT, was graded by the investigator according to accepted institutional practice: CIBMTR grading for Acute GVHD; NIH Consensus criteria for Chronic GVHD.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        1
        description
        Standard of Care Consolidation (HCT) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: 1. Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) 2. Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) 3. Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT); HMA-based induction subjects: Are candidates for (as determined by the investigator) and receive HCT Allogeneic HCT: Allogeneic HCT
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        1
        serious Num Affected
        0
        serious Num At Risk
        1
        title
        Evaluable Cohort - Transplant Arm
      2. deaths Num Affected
        1
        deaths Num At Risk
        6
        description
        Standard of Care Consolidation (cytarabine-based chemo) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: 1. Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) 2. Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) 3. Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT) Consolidation chemotherapy: Cytarabine-based consolidation chemotherapy
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        6
        serious Num Affected
        0
        serious Num At Risk
        6
        title
        Evaluable Cohort - Consolidation Chemo Arm
      3. deaths Num Affected
        0
        deaths Num At Risk
        4
        description
        Enrolled subjects who do not achieve a CR to induction therapy, regardless of diagnostic phenotype. Following completion of induction therapy and remission bone marrow aspirate, if a subject is determined to not have achieved a complete remission to induction therapy, he or she would be included in observational cohort 1.
        id
        EG002
        other Num Affected
        0
        other Num At Risk
        4
        serious Num Affected
        0
        serious Num At Risk
        4
        title
        Observational Cohort 1
      4. deaths Num Affected
        4
        deaths Num At Risk
        7
        description
        Enrolled subjects who achieve a CR to induction therapy but meet one or more of the following criteria: * Lack the immunophenotype of interest, * Cytarabine based induction subjects: Are not candidates for \[as determined by the investigator (e.g. unfit or refusal)\] and do not receive consolidation therapy (cytarabine-based chemotherapy or HCT) * HMA-based induction subjects: Are not candidates for \[as determined by the investigator (e.g. unfit, lack of donor, refusal)\] and do not receive HCT Final investigator determination of fit-ness can occur at any time until the start of consolidation therapy. HMA-based induction subjects will not receive consolidation cytarabine-based chemotherapy as part of the evaluable cohort if they do not receive HCT.
        id
        EG003
        other Num Affected
        0
        other Num At Risk
        7
        serious Num Affected
        0
        serious Num At Risk
        7
        title
        Observational Cohort 2
      frequency Threshold
      0
      time Frame
      Graft Versus Host Disease (GVHD) events were collected from the time of consolidation HCT through long term follow-up (up to approximately 5 years). - Acute GVHD: Confirmed GVHD within 100 days of HCT. - Chronic GVHD: Confirmed GVHD 100 days or more after HCT.

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice